The Asthma Monitor AM3 / AM3 BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM3 / AM3 BT measures the flow during expiration serving for the calculation of further parameters as FEV1.

The AM3 / AM3 BT is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management.

The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEV1). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician.

The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life" status. When enabled, the AM3 / AM3 BT can be programmed with a couple of questions, where the patient can select then from a couple of different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS.

The AM3 / AM3 BT is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM3 / AM3 BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.

Device Description

The Asthma Monitor AM3 is a medical device (peak flow meter with symptom diary) providing following characteristics:

Handheld device
Battery operation
Storing capacity of 400 measurements
Storing capacity of 200 sets of questionnaires (each 12)
Measurement Parameters: PEF and FEV1
Accuracy Flow: ± 5% or ± 20 l/min
Accuracy Volume: ± 3% or ± 0.05 liter
Data transmission to computer via USB, Bluetooth and Serial
Flow sensor (single patient use)
Mouthpiece (single patient use)

AI/ML Overview

The provided document is a 510(k) Summary for the Asthma Monitor AM3 / AM3 BT. This submission primarily focuses on demonstrating substantial equivalence to a predicate device, particularly regarding the addition of Bluetooth data transmission. It is not an effectiveness study as typically performed for novel algorithms or diagnostic devices.

Therefore, many of the requested categories for a study proving device performance, especially those related to clinical accuracy, ground truth, and expert evaluation, are not applicable in this context. The document describes engineering and regulatory compliance testing rather than clinical performance studies.

Here's a breakdown of the information that can be extracted or that is not applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance specifications and indicates that safety and EMC testing was conducted for the modified device, but it doesn't present a table of acceptance criteria and reported device clinical performance in the way this question typically implies for diagnostic algorithms.

Characteristic	Acceptance Criteria (Predicate)	Reported Device Performance (AM3 / AM3 BT)
Accuracy Flow	± 5% or ± 20 l/min	Identical (implied, per substantial equivalence to predicate which had this spec)
Accuracy Volume	± 3% or ± 0.05 liter	Identical (implied, per substantial equivalence to predicate which had this spec)
Data Transmission	Serial RS 232 & USB	Serial RS 232 & USB & Bluetooth (additional)
Bluetooth Module	(Specifics for AM1+ BT predicate: WML-C46)	Identical (WML-C46)
Safety Testing	Satisfaction of all safety requirements and mitigation of all identified hazards	Demonstrated satisfaction of all safety requirements and mitigation of all identified hazards
EMC Testing	Compliance with EN 60601-1-2	Performed according EN 60601-1-2
Software Dev.	Compliance with IEC 601-1-4 Standard	Developed according to IEC 601-1-4 Standard

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This submission focuses on engineering modifications (adding Bluetooth) and demonstrating equivalence to existing devices, not on a clinical performance study with a "test set" of patient data for algorithm evaluation in the way the question implies. The testing done was likely functional and safety testing of the device hardware and software.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No ground truth establishment by medical experts for a test set is described or required for this type of 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is relevant to this submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is not an AI/algorithm-focused submission. It's for a diagnostic spirometer with an added data transmission method (Bluetooth).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a measurement device (spirometer), not a standalone algorithm/AI without human input. Its function is to provide quantifiable measurements (PEF, FEV1) to the patient and physician.

7. The Type of Ground Truth Used

Not applicable. Ground truth, in the context of clinical accuracy or diagnostic performance, is not discussed as this submission focuses on device equivalence and safety for a new data transmission method. The "truth" for the device's measurements would be established through mechanical calibration and validation against known standards, not by expert consensus on clinical cases.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set is mentioned or relevant to this submission.

Summary of the Study Discussed in the Document:

The "study" described in the 510(k) summary is primarily engineering and regulatory compliance testing to support a Special 510(k) submission for a device modification (adding Bluetooth data transmission).

The key elements are:

Objective: To demonstrate substantial equivalence of the Asthma Monitor AM3 with Bluetooth (AM3 BT) to its predicate device (Asthma Monitor AM3 K980876/A2) and a similar predicate with Bluetooth (Asthma Monitor AM1+ / AM1+ BT K090486), specifically for the added Bluetooth functionality.
Methodology:
- Comparison: A direct comparison table shows the characteristics of the new AM3 BT against the original AM3 and the AM1+ BT. The critical point is that the Bluetooth module in the AM3 BT is identical to the one used in the already cleared AM1+ BT.
- Development Standards: The Bluetooth data transmission was developed in accordance with Cardinal Health's standard operating procedures (Design Control).
- Risk Analysis: A Failure Modes and Effects Analysis (FMEA) was performed to assess the impact of the added Bluetooth.
- Safety Testing: Procedures were followed to demonstrate satisfaction of all safety requirements and mitigation of identified hazards.
- EMC Testing: Performed according to EN 60601-1-2.
- Software Development: Followed IEC 601-1-4 Standard.
Conclusion: Based on these engineering and regulatory compliance measures, the submitter concluded that the Asthma Monitor AM3 with the "Bluetooth" data transmission module is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use, performing at least as well as the predicate devices.

Summary

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K0928&J

510(k) Summary

JAN 1 3 2010

GENERAL INFORMATION

5.1 Type of Submission

Special 510(k) Submission

Submission date: 09/03/2009

5.2 Submitter

Name:

CareFusion Germany 234 GmbH (formerly: Cardinal Health Germany 234 GmbH)

Address:

Phone:

FAX:

E-mail

Leibnizstrasse 7 D-97204 Hoechberg Germany

Contact person in Germany:

Address:

Elmar Niedermeyer CareFusion Germany 234 GmbH Leibnizstrasse 7, 97204 Hoechberg Germany +49 931 49 72 - 361 +49 931 49 72 - 62361 Elmar. Niedermeyer@carefusion.com

Contact person in the U.S .: (Official Correspondent) Thomas Gutierrez Address

Phone/Fax:

CareFusion 22745 Savi Ranch Parkway Yorba Linda, CA 92887 714-919-3342 Thomas. Gutierrez@carefusion.com

. -

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5.3 Establishment Registration Number 9615102
Common Name or Classification Name 5.4 Diagnostic Spirometer (CFR 868.1840, Product Code BZG)

5.5 Trade Name Asthma Monitor AM3 / AM3 BT

5.6 Device Classification This is a Class II device

5.7 Classification Panel

73 Anesthesiology Part 868 Code BZG

5.8 Reason for Premarket Notification

Device modification to an existing Cardinal Health - device regarding "The New 510(k) Paradigm" -- Additional data transfer to computer by blue tooth --

5.9 Legally predicate marketed device

Asthma Monitor AM3 K980676/A2 Code BZG

Asthma Monitor AM1+ / AM1+ BT K090486 Code BZG

Predicate Device Company 5.10

CareFusion Germany 234 GmbH (formerly: Cardinal Health Germany 234 GmbH)

Device Description 5.11

The Asthma Monitor AM3 is a medical device (peak flow meter with symptom diary) providing following characteristics:

. Handheld device
Battery operation ●
Storing capacity of 400 measurements .
Storing capacity of 200 sets of questionnaires (each 12) o
Measurement Parameters: PEF and FEV1 ●
Accuracy Flow: ± 5% or ± 20 l/min ●
Accuracy Volume: ± 3% or ± 0.05 liter ●
Data transmission to computer via USB, Bluetooth and Serial .
Flow sensor (single patient use)
Mouthpiece (single patient use) .

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5.12 Intended Use Statement

medicine.

· 5.13 · Required Components AM3 / AM3 BT measurement device Accessories User Manual

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5.14 Summary Table of Comparison

a) Comparison with Asthma Monitor AM3 with 510(k) K980876/A2

	Asthma Monitor AM3(K980876/A2)	Asthma Monitor AM3with Bluetooth
Indicationsfor Use	The Asthma Monitor AM fromCardinal Health is an electronicmeasurement device to monitor thelung function (determination of therespiratory flows and volume) withhigh reproducibility wherever andwhenever is a need of. The AMmeasures the flow during expirationserving for the calculation of furtherparameters as FEV1.The AM is used to monitor therespiratory status of human beings inthe areas asthma, chronic obstructivepulmonary disorder and in areas likeoccupational medicine, clinical trialsand disease management.The patient is informed of the resultsby numeric values for selectedparameters (e.g. PEF, FEV1).Furthermore a visual control unit,displayed as a kind of traffic lights,allows an immediate indication of themeasurement based on criteriadefined by the patient's physician.The device saves the results of ameasurement (always with date andtime) automatically in an internaldatabase. The memory capacity isdesigned to store up to 400measurements. In addition, aquestionnaire functionality can becalled up by the use of a softwarepackage (AMOS) to record e.g. the"Quality of Life" status. Whenenabled, the AM can be programmedwith a couple of questions, where thepatient can select then from a coupleof different answers. This informationis also stored in the internal databaseand can be transmitted for evaluationto a standard PC using the softwarepackage AMOS.The AM is designed to replaceordinary peak flow meter, diary andpencil by a single system. Easyhandling, sturdy and handy designallow the Asthma Monitor AM beingused almost everywhere: at work, athome, in school, for experts opinion,research or clinical trial purposes and	identical
Patientpopulation	The Asthma Monitor can be used forpatients from 4 years on and older.	identical
Dimensions(housing)	Length x Width x Height:1128237 mmWeight:167 g (batteries included)	identical
Display	LCD moduleSize: 54,0 x 33,5 mm255 x 160 dots	identical
Key-panel	Foil Key-panel (4 keys):- ESC (on/off)- UP-ARROW- DOWN-ARROW- OK	identical
Integratedmouthpiece(material)	Polysterol 454C	identical
Single Usemouthpiece(material)	Bormed RG835 MO	identical
Performance(measurements)	Parameters:PEFFEV1	identical
Interface	Serial RS 232 & USB	Serial RS 232 & USB & Blue-tooth
Energy type	3 x 1,5 (Micro AAA)	identical
OperatingRequire-ments	PC software AMOS	identical
	Asthma Monitor AM1+/ AM1+ BT K090486	Asthma Monitor AM3with Bluetooth
Bluetoothinterface	WML-C46 (Manufactured byMitsumi Electric Co. LTD)	Identical
BluetoothPowerSupply	3.3 Vdc	Identical
BluetoothTransmitPower	2.65 dBm E.I.R.P.	Identical
BluetoothFrequencyRange	2.402GHz - 2.480GHz	Identical
BluetoothModulationTechnique	Frequency Hopping SpreadSpectrum (FHSS) (GFSK)	Identical
BluetoothNumber ofChannels	79	Identical
BluetoothDwell Time	<= 0.4s	Identical
BluetoothOperatingMode	Point-to-Point	Identical
BluetoothData Rate	741 Kps (Highest Mode)	Identical
BluetoothAntennaType	Chip Antenna	Identical
BluetoothAntenna Gain	2.0 dBi	Identical

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CareFusion Germany 234 GmbH

АМЗ / АМЗ ВТ 1

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Discussion to the table above:

The insignificant difference to the AM3 K980876/A2 is:

Bluetooth is used for data transfer to the computer as an additional . possibility besides the serial and USB interface communication.
b) Comparison with Asthma Monitor AM1+ / AM1+ BT with 510(k) K090486

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Discussion to the table above:

The similarity to the AM1+ / AM1+ BT is found as:

Bluetooth is used for data transfer. The Bluetooth module for the AM3 . device is identical to the Bluetooth module in the AM1+ / AM1+ BT. Both devices work with the Bluetooth module WML-C46 manufactured by Mitsume Electric Co. LTD. As a consequence of this all Bluetooth
- 4 parameters of the AM3 BT are identical to the predicate device AM1+ BT.

5.15 Summary of Device Testing

The following practices were followed and monitored for development of the Asthma Monitor AM3 with the Bluetooth data transmission:

The Bluetooth data transmission for the above device was developed in . accordance with the Cardinal Health development standard operating procedures (000490 09 - Design Control).
The risk analysis method used to assess the impact of Asthma Monitor . AM3 with the additional Bluetooth data transmission was a Failure Modes and Effects Analysis (FMEA).
. Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards.
. The EMC testing was performed according EN 60601-1-2.
The software was developed according to the IEC 601-1-4 Standard. .

5.16 Conclusions

Based on the above, CareFusion Germany 234 GmbH concludes that the Asthma Monitor AM3 with the "Bluetooth" data transmission module is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use, and performs at least as well as the predicate devices.

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Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling an emblem. The emblem is a stylized representation of a bird, possibly an eagle, with its wings spread, symbolizing protection and care. The seal is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Elmar Niedermeyer Regulatory Affairs Specialist CareFusion Germany 234 GmbH Leibnizstrasse 7 Hoechberg GERMANY 97204

Re: K092890

Trade/Device Name: AM3 AM3BT Regulation Number: 21CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: December 3, 2009 Received: December 14, 2009

Dear Ms. Nidermeyer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

JAN 1 3 2010

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Ms. Nidermeyer

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health.'s (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR.regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

ph for

Anthony D. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K

Device Name:

AM3 AM3 BT

Indications for Use:

The Asthma Monitor AM3 / AM3 BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproduction wherever and whenever is a need of. The AM3 / AM3 BT measures the flow during expiration serving for the calculation of further parameters as FEV1.

The AM3 / AM3 BT is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmoner the respiration y status of numal beings in the areas astimal trials and disease management.

The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 600 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life" status. When enabled, the AM3 / AM3 BT can be programmed with a couple of questions, where the patient can select then from a couple of different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS.

The AM3 / AM3 BT is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the AM3 / AM3 BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational

medicine.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	4092890
	Page 1 of

Regulation Number and Section

§ 868.1840 Diagnostic spirometer.

(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).